Benzinga | Dec 20, 2021 07:11AM EST

MediWound Announces Positive Initial Data From Its U.S. Phase 2 Pharmacology Study Of EscharEx Showing Effective And Rapid Debridement In Chronic And Hard To Heal Wounds

MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced positive initial data from seven of the maximum fifteen patients in its ongoing open-label, phase 2 pharmacology study of EscharEx(r), the company's next-generation enzymatic debridement agent under development for chronic and hard-to-heal wounds. The company expects to share the full data set from this study in the first half of 2022.

Based on the data generated to date, following treatment of seven patients with either diabetic foot ulcers (DFU's) or venous leg ulcers (VLU's), EscharEx demonstrated safe and effective debridement of lower leg ulcer within a few daily applications. In addition, evaluation of wounds' tissue samples (biopsies) and fluorescence images, indicated reduction of biofilm and bacterial load following the treatment with EscharEx.

"The data from this pharmacology study, which is in-line with the results of our previous phase 2 study in both VLU's and DFU's, clearly supports EscharEx as a potential triple threat in the treatment of chronic wounds with its effective wound debridement, disruption of biofilm, and reduction of bacterial load," said Sharon Malka, Chief Executive Officer of MediWound. "We believe that EscharEx, with its attractive product profile, can meaningfully improve wound care treatment over the current standard of care. Additionally, we look forward to sharing topline data from our ongoing EscharEx U.S. phase 2 adaptive design study in the first quarter of 2022."

Dr. Robert Snyder, Chief Medical Director of EscharEx program added "We are very pleased to see the initial data show that EscharEx could effectively debride wounds while disrupting biofilm and lowering bacterial bioburden. There is wide consensus among clinicians that infection and microbial biofilm impedes the healing process and prolongs wound healing. The pharmacology study provides us with a better understanding of what is happening in the wound bed, both during and after debridement with EscharEx."

The phase 2 pharmacology study, which remains ongoing, is a prospective, open label, single-arm study, being conducted at three U.S. clinical sites. The study is designed to evaluate the clinical performance, safety, and pharmacology effect of EscharEx in the debridement of lower leg ulcers (VLUs and DFUs) in up to fifteen patients. The study evaluates the safety and efficacy of debridement as measured by incidence of, and time to complete debridement. In addition, the study evaluates the pharmacological effects of EscharEx as measured by the changes from baseline to end of treatment period in (1) wound biofilm presence in wound biopsies, (2) bacterial burden measured by MolecuLight(r) fluorescence images, and (3) biomarkers of wound healing and inflammation in wound fluid.